HANZEMA CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-10-2022
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Active ingredient:
ALITRETINOIN
Available from:
DR. REDDY'S LABORATORIES INC
ATC code:
D11AH04
INN (International Name):
ALITRETINOIN
Dosage:
30MG
Pharmaceutical form:
CAPSULE
Composition:
ALITRETINOIN 30MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Product summary:
Active ingredient group (AIG) number: 0137581003; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-08-20
Summary of Product characteristics
_Page 1 of 40_
_HANZEMA _
PRODUCT MONOGRAPH
HANZEMA
Alitretinoin
Capsules
10 mg and 30 mg
Immunomodulator
/ Anti-inflammatory agent
DIN OWNER:
DR. REDDY’S LABORATORIES, INC.
Princeton, NJ – 08540 USA
IMPORTED BY:
DR. REDDY’S LABORATORIES CANADA INC.
Mississauga, ON L4W 4Y1 CANADA
Date of Preparation:
June 18, 2018
Date of Revision:
October 20, 2022
SUBMISSION CONTROL NO.: 264229
™
_Page 2 of 40_
_HANZEMA _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................. 3
INDICATIONS AND CLINICAL USE
.......................................................................
3
CONTRAINDICATIONS
.........................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................
5
ADVERSE REACTIONS
........................................................................................
12
DRUG INTERACTIONS
........................................................................................
15
DOSAGE AND ADMINISTRATION
.......................................................................
18
OVERDOSAGE
....................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 19
STORAGE AND STABILITY
.................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
................................................................. 22
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 22
PART II: SCIENTIFIC INFORMATION
.......................................................................
23
PHARMACEUTICAL INFORMATION
................................................................... 23
CLINICAL TRIALS
..............................................................
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